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Feasibility and Safety of FLOT Regimen in Chinese Gastric Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03646591
Recruitment Status : Completed
First Posted : August 24, 2018
Last Update Posted : August 24, 2018
Sponsor:
Information provided by (Responsible Party):
BIRENDRA KUMAR SAH, Ruijin Hospital

Brief Summary:
Neoadjuvant chemotherapy for advanced stage gastric cancer is justified by various studies, however, there was not any large scale RCT to support it until German oncologist introduced a novel regimen(FLOT regimen) in 2017. Investigator assessed FLOT regimen for safety and feasibility in Chinese gastric cancer patients.

Condition or disease Intervention/treatment
Chemotherapy Effect Drug: Chemotherapy

Detailed Description:
Neoadjuvant chemotherapy for advanced stage gastric cancer is justified by various studies, however, there was not any large scale RCT to support it until German oncologist introduced a novel regimen(FLOT regimen) in 2017. FLOT regimen was prescribed for German patients and various questions are raised by experts from Eastern countries. As the FLOT regimen was officially included in NCCN 2018 guidelines, investigator used standard protocol of FLOT regimen on Chinese gastric cancer patients. Safety and feasibility was assessed carefully to provide basic data for further large scale studies in China.

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Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study on Feasibility and Safety of FLOT Regimen in Chinese Gastric Cancer Patients
Actual Study Start Date : November 15, 2017
Actual Primary Completion Date : August 20, 2018
Actual Study Completion Date : August 20, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Group/Cohort Intervention/treatment
Neoadjuvant chemotherapy
A total of four preoperative and four postoperative cycles of FLOT chemotherapy administered A cycle consist of Day 1 5-FU 2600mg/M2 administered via intravenous PICC for 24 hour Leucovorin 200mg/M2 intravenous Oxaliplatin 85mg/ M2 intravenous Docetaxel 50mg/M2 intravenous Repeated every 15th day
Drug: Chemotherapy
5-FU+CF+Docetaxel+Oxaliplatin




Primary Outcome Measures :
  1. Completion rate of preoperative FLOT regimen [ Time Frame: upto 3 months ]
    How many patients completed the plan preoperative chemotherapy regimen


Secondary Outcome Measures :
  1. Adverse events [ Time Frame: Upto three months ]
    Chemotherapy related adverse events according to the CTCAE version 3.0

  2. Pathological response rate [ Time Frame: Upto three months ]
    According to tumor regression grading(TRG)

  3. Postoperative morbidity [ Time Frame: Upto one month after hospital discharge ]
    Postoperative complications

  4. Postoperative mortality [ Time Frame: Upto one month after hospital discharge ]
    Death due to surgical complication



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cohort of operable gastric cancer patients.
Criteria

Inclusion Criteria:

  • Pathology confirmed gastric cancer with cTNM stage III
  • Clinically fit for gastric cancer surgery

Exclusion Criteria:

  • Clinically unfit for gastric cancer surgery
  • Distant metastases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03646591


Locations
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China, Shanhgai
Ruijin Hospital
Shanghai, Shanhgai, China, 200025
Sponsors and Collaborators
BIRENDRA KUMAR SAH
Investigators
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Principal Investigator: BIRENDRA K SAH, Ph D Ruijin Hospital

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Responsible Party: BIRENDRA KUMAR SAH, Surgeon, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT03646591     History of Changes
Other Study ID Numbers: Ruijin GCS-Neoadjuvant
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by BIRENDRA KUMAR SAH, Ruijin Hospital:
gastric cancer
neoadjuvant chemotherapy
FLOT regimen

Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases